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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bradley D Spear 6/3/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-30977
Telephone: (513) 679-2700
      FAX: (513) 679-2761

 

 
June 3, 2011
                                                                                                                                   
WARNING LETTER
CIN-11-188692-18
 
Via United Parcel Service
                                                                                                     
 
Mr. Bradley D. Spear, Owner
Bradley D. Spear
1648 Whites Chapel Road
Glasgow, KY 42141-7890
 
Dear Mr. Spear:
 
On March 17, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle farm operation located at 1648 Whites Chapel Road, Glasgow, KY 42141. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov
 
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
 
Specifically, our investigation revealed that on or about October 25, 2010, you sold a cow, identified with back tag # (b)(4) for slaughter as food.  On or about October 27, 2010, (b)(4)slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of gentamicin in the kidney tissue and sulfamethazine at 2.78 parts per million (PPM) in the liver. FDA has established a tolerance of 0.1 PPM for residues of sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.640 (21 C.F.R. § 556.640). Additionally, FDA has not established a tolerance for residues of gentamicin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.300 (21 C.F.R. § 556.300). The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).
 
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records, failed to maintain a drug inventory system and failed to inquire about the medication status of animals purchased for slaughter. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
 
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
 
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. 
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
Your written response should be sent to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 Ext. 2134.
 
Sincerely yours,
/S/
Teresa C. Thompson
District Director
Cincinnati District Office
 
cc:    Dr. Isabel Arrington, Director TA/C
         United States Department of Agriculture (USDA)
         Food Safety and Inspection Service
         Landmark Center, Suite 300
         1299 Farnam Street
         Omaha, Nebraska 68102